Evidence map›Paper›PMID 41264554›Full record

ArticleDiabetes care2026

The Role of Adaptive and Innovative Trial Designs in Diabetes Research: A Scoping Review.

Ashni Goshrani, Rose Lin, Leonid Churilov, Michele Gaca, Christine Sommerville, Andrew Farmer, Kamlesh Khunti, Elizabeth Holmes-Truscott, Negar Naderpoor, David O'Neal and 2 more

Abstract readScoping Review
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes care, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Ashni GoshraniDepartment of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville, Victoria, Australia.ORCID 0009-0008-4699-2531
Rose LinEndocrinology Department, Eastern Health, Melbourne, Victoria, Australia.
Leonid ChurilovDepartment of Medicine, Melbourne Medical School, The University of Melbourne, Melbourne, Victoria, Australia.
Michele GacaDepartment of Medicine, Melbourne Medical School, The University of Melbourne, Melbourne, Victoria, Australia.ORCID 0000-0001-7350-3299
Christine SommervilleDepartment of Medicine, Melbourne Medical School, The University of Melbourne, Melbourne, Victoria, Australia.
Andrew FarmerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, U.K.
Kamlesh KhuntiDiabetes Research Centre, University of Leicester, Leicester, U.K.ORCID 0000-0003-2343-7099
Elizabeth Holmes-TruscottAustralian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne, Carlton, Victoria, Australia.
Negar NaderpoorCentre for Research and Education in Diabetes and Obesity, Austin Health, Heidelberg, Victoria, Australia.
David O'NealAustralian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne, Carlton, Victoria, Australia.ORCID 0000-0002-0870-4032
Rury R HolmanAustralian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne, Carlton, Victoria, Australia.ORCID 0000-0002-1256-874X
Elif I EkinciDepartment of Medicine, Melbourne Medical School, The University of Melbourne, Melbourne, Victoria, Australia.ORCID 0000-0003-2372-395X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdaptive and master protocol clinical trials offer significant advantages for diabetes research, including enhanced efficiency and personalized treatment strategies. PURPOSE: This scoping review aimed to systematically map the use of adaptive and master protocol designs in interventional trials for type 1 and type 2 diabetes, identify research gaps, and highlight opportunities for broader implementation. DATA SOURCES: A systematic literature search was performed using MEDLINE, Embase, CENTRAL, Emcare, Global Health, Web of Science, and clinical trial registries. Gray literature searches complemented database findings. STUDY SELECTION: Studies using adaptive, platform, basket, or umbrella trial designs in people with type 1 or type 2 diabetes were included. DATA EXTRACTION: Data were charted using a standardized form. Extracted variables included diabetes type, trial design, adaptive features, interventions, end points, and key findings. DATA SYNTHESIS: Of 396 articles screened, 6 published adaptive trials met the inclusion criteria: 3 in type 1 diabetes, 1 in type 2 diabetes, and 2 in diabetes-related neuropathy. Most used adaptive features for dose finding, response-adaptive randomization, and sample size reestimation. No published platform, basket, or umbrella trials were identified. Six ongoing adaptive trials in type 1 diabetes were identified through registry searches, four under an adaptive platform master protocol. LIMITATIONS: Despite a comprehensive search, some gray literature and unpublished studies may have been missed. Risk of bias was not assessed, consistent with scoping review methodology.

conclusionsAdaptive and master protocol trials remain rare in diabetes. Overcoming barriers through targeted training and awareness, robust regulatory frameworks, and strategic incentives could support broader adoption.

Indexed as

Clinical Trials as TopicDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Research DesignHumans

Identifiers

PMID41264554
PMCPMC12719716

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.